MG1113A / GC Biopharma - LARVOL DELTA

Mechanism and kinetics study of MG1113, an anti-tissue factor pathway inhibitor antibody promoting hemostasis in hemophilia. (PubMed, Res Pract Thromb Haemost) - "By systematically lowering the threshold for tissue factor-mediated initiation, MG1113 facilitates physiological restoration of hemostasis. This mechanistic profile-combined with gradual clot kinetics and the advantages of a monoclonal antibody-makes MG1113 suited for routine prophylaxis."

Journal • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Safety, Pharmacokinetics, and Hemostatic Efficacy of MG1113, a Subcutaneous Anti-TFPI Antibody, in Severe Hemophilia A and B: A Phase 1b Dose-Escalation Study (ISTH 2026) - "However, the dose-dependent elevation of D-dimer and PF1+2 highlights the need for cautious dose titration and rigorous coagulation monitoring in future late-phase trials to mitigate potential thrombotic risks inherent to the anti-TFPI class. DOI*10.1016/j.rpth.2026.104850"

Clinical • First-in-human • P1 data • PK/PD data • Cardiovascular • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases

Refined target-mediated drug disposition modeling of the anti-tissue factor pathway inhibitor antibody MG1113 in cynomolgus monkeys and rabbits. (PubMed, Front Pharmacol) - "The refined TMDD model better characterized the nonlinear pharmacokinetic and pharmacodynamic profiles of MG1113 across species by incorporating both targets and delayed absorption after s.c. dosing. This model enabled quantitative prediction of sTFPI-α suppression in relation to MG1113 dose and baseline target levels, supporting a rational dose selection for ongoing and future clinical studies."

Journal • Preclinical • Hematological Disorders • Hemophilia • Rare Diseases • SPINT2

mRNA based in vivo MG1113 antibody production as a potential therapeutic approach for hemophilia. (PubMed, J Control Release) - "This study explores an mRNA-LNP platform for antibody delivery in hemophilia, offering the potential for prolonged pharmacological activity, simplified manufacturing, and flexible therapeutic application. Taken together, our findings suggest that mRNA LNP systems could advance next-generation antibody-based treatment strategies for bleeding disorders and potentially other diseases."

Journal • Preclinical • Gene Therapies • Hematological Disorders • Hemophilia • Rare Diseases

A Phase 1b Study to Assess the Safety, Tolerability, PK and PD of MG1113 in Hemophilia Patient (clinicaltrials.gov) - P1 | N=15 | Completed | Sponsor: GC Biopharma Corp | Trial primary completion date: Jul 2024 ➔ Dec 2024 | Recruiting ➔ Completed | Phase classification: P1b ➔ P1

Phase classification • Trial completion • Trial primary completion date • Hematological Disorders • Hemophilia • Rare Diseases

A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MG1113 in Healthy Subjects and Hemophilia Patients (ISTH 2023) - P1 | "A dose-dependent systemic exposure of MG1113 in the SC group was observed in both healthy and hemophilia participants. After MG1113 treatment, free TFPI and FXa (residual TFPI) activity were decreased and both diluted PT and lag time (TGA) were shortened. However, peak height (TGA), ETP (endogenous thrombin potential, TGA), D-dimer, and prothrombin fragment 1+2 increased compared to the baseline."

Clinical • P1 data • PK/PD data • Cardiovascular • Hematological Disorders • Hemophilia • Pain • Rare Diseases • Thrombosis • Venous Thromboembolism

A Phase 1 study of the safety; tolerability; pharmacokinetics and pharmacodynamics of MG1113 in healthy subjects and hemophilia patients (ICKSH 2023) - P1 | "MG1113 also exhibited a desirable PK profile showing a dose-dependent systemic exposure. Keyword : Antibodies, Monoclonal, Hemophilia, Pharmacokinetics, Pharmacodynamics, Safety"

Clinical • P1 data • PK/PD data • Cardiovascular • Hematological Disorders • Hemophilia • Pain • Rare Diseases • Thrombosis • Venous Thromboembolism

A Phase 1b Study to Assess the Safety, Tolerability, PK and PD of MG1113 in Hemophilia Patient (clinicaltrials.gov) - P1b | N=15 | Recruiting | Sponsor: GC Biopharma Corp | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Hemophilia • Rare Diseases

A Phase 1b Study to Assess the Safety, Tolerability, PK and PD of MG1113 in Hemophilia Patient (clinicaltrials.gov) - P1b | N=15 | Not yet recruiting | Sponsor: GC Biopharma Corp

New P1 trial • Hematological Disorders • Hemophilia • Rare Diseases

A Study to Investigate the Safety, Tolerability, PK and PD of MG1113 in Healthy Subjects and Hemophilia Patients (clinicaltrials.gov) - P1; N=41; Completed; Sponsor: Green Cross Corporation; Recruiting ➔ Completed

Clinical • Trial completion • Hematological Disorders • Hemophilia • Rare Diseases

A Study to Investigate the Safety, Tolerability, PK and PD of MG1113 in Healthy Subjects and Hemophilia Patients (clinicaltrials.gov) - P1; N=41; Recruiting; Sponsor: Green Cross Corporation; Trial completion date: Jan 2020 ➔ Aug 2021; Trial primary completion date: Oct 2019 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Hematological Disorders • Hemophilia • Rare Diseases

Target-Mediated Drug Disposition (TMDD) Modeling of an Anti-TFPI Antibody (MG1113) in Cynomolgus Monkeys to Predict Human Pharmacokinetics and Pharmacodynamics. (PubMed, J Thromb Haemost) - "MG1113 showed nonlinear PK after both IV and SC administrations at the dosing range from 2.5~10 mg/kg. The concentrations of MG1113 vs. TFPI could be characterized a dose-response relationship using a TMDD model. The TMDD modeling and simulation built in this study were used to simulate various dosage regimens of MG1113 to apply to the first-in-human study design, and moreover expected to be referred to establish the dose for further clinical trials."

Journal • PK/PD data • Hematological Disorders • Hemophilia • Rare Diseases

MG1113, a specific anti-tissue factor pathway inhibitor antibody, rebalances the coagulation system and promotes hemostasis in hemophilia. (PubMed, Res Pract Thromb Haemost) - "Intravenous or subcutaneous injection of MG1113 into HA-induced rabbits resulted in rebalancing of blood loss, mPT, and free TFPI levels. These results indicate that subcutaneous administration of MG1113 neutralizes the function of TFPI and regulates bleeding in individuals with hemophilia."

Journal • Hematological Disorders • Hemophilia • Rare Diseases

[VIRTUAL] MG1113, a specific anti-TFPI antibody, rebalances the coagulation system and promotes hemostasis in hemophilia (WFH 2020) - "These results suggest that the TFPI-neutralizing antibody, MG1113, may be effective in controlling the bleeding of hemophilia patients via IV and SC routes of administration, and could be a significant therapeutic alternative for the patients."

Gene Therapies • Hematological Disorders • Hemophilia • Rare Diseases • F2

GC starts P1 trials of hemophilia treatment (Korea Biomedical Review) - "GC said Thursday that it has administered the first dose of MG1113, a hemophilia treatment, to a patient participating in phase 1 clinical trial for the drug. The company plans to evaluate the safety of MG1113 in 49 healthy adults and hemophilia patients at two hospitals -- Severance Hospital and Korea University Anam Hospital." "

Trial status